FDA Commissioner Margaret A. Hamburg, MD, recently released the agency’s Global Engagement Report, detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The report describes the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.
“As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world,” said Dr. Hamburg.
Global production of FDA-regulated goods and materials has exploded over the past decade and continues to grow. FDA-regulated products originate from more than 150 countries, 130,000 importers, and 300,000 foreign facilities. Each year from 2005 to 2011, imports of pharmaceutical products have increased at nearly 13% and device imports have grown more than 10%. More than 80% of the active pharmaceutical ingredients used to make medicines are imported.
The report outlines a variety of engagement strategies the FDA is using in partnership with other agencies, organizations, and coalitions around the world to strengthen global, regulatory capacity-building efforts; develop and harmonize science-based regulatory standards; increase awareness about the importance of regulatory systems; and share information and data globally to facilitate rapid identification of and response to public health emergencies.
Through its international offices in Africa, Asia, Europe, Latin America, and the Middle East, the FDA is increasing its knowledge base about local regulatory systems and landscapes. The agency is also increasing the understanding of foreign governments and industry of FDA regulations and standards for products destined for U.S. consumers, and collaborating to strengthen regulatory science and evidenced-based approaches to product safety and quality. All of this furthers the FDA’s implementation of its global strategy, set forth in the agency’s special report, Pathway to Global Product Safety and Quality, released last year. ■